Cardiovascular

LABORATORIOS LINCOSA S.A., SPAIN; INBIOTECH LTD., BULGARIA

VN-23033-22

19/04/2022

Inbiotech Ltd.

Telmisartan; Hydrochlorothiazide

80mg; 25mg

Treatment of essential hypertension.
Telsol Plus 80 mg/12.5 mg (telmisartan 80 mg/hydrochlorothiazid 12.5 mg) fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on Telsol (telmisartan) alone.

Adults
• Telsol Plus 80 mg/12.5 mg should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone. Individual dose titration with each of the two components is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered
• Telsol Plus 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 80 mg.
Special populations:
Renal impairment: Periodic monitoring of renal function is advised.
Hepatic impairment
In patients with mild to moderate hepatic impairment the posology should not exceed Telmisartan/Hydrochlorothiazide 40 mg/12.5 mg once daily. Telsol Plus is not indicated in patients with severe hepatic impairment. Thiazides should be used with caution in patients with impaired hepatic function.
Elderly
No dosage adjustment is necessary.
Paediatric population
The safety and efficacy of Telsol Plus in children and adolescents aged below 18 have not been established.

36

Tablet

Box of 2 blisters x 14 tablets